Famotidine (Famotidine)

Trade Name : Famotidine

Baxter Healthcare Corporation

INJECTION, SOLUTION

Strength 20 mg/50mL

FAMOTIDINE Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]

Delivery Process

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Famotidine (Famotidine) which is also known as Famotidine and Manufactured by Baxter Healthcare Corporation. It is available in strength of 20 mg/50mL per ml. Read more

Famotidine (Famotidine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • The active ingredient in Famotidine Injection is a histamine H-receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is CHNOS and its molecular weight is 337.45. Its structural formula is:
  • Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.
  • Famotidine Injection is supplied as a sterile solution, for intravenous use only, in plastic single dose GALAXY containers. Each 50 mL of the premixed, iso-osmotic intravenous injection contains 20 mg Famotidine, USP, and the following inactive ingredients: L-aspartic acid 6.8 mg, sodium chloride, USP, 450 mg, and Water for Injection. The pH ranges from 5.7 to 6.4 and may have been adjusted with additional L-aspartic acid and/or with sodium hydroxide.
  • The GALAXY plastic container is fabricated from a specially designed multilayer plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
  • No data
  • No data
  • Famotidine Injection is supplied as a premixed solution in GALAXY plastic containers (PL 2501 Plastic) and is intended for intravenous use only. Famotidine Injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the following conditions:
  • Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore, Famotidine Injection should not be administered to patients with a history of hypersensitivity to other H-receptor antagonists.
  • No data
  • The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which famotidine tablets were compared to placebo, the incidence of adverse experiences in the group which received famotidine tablets, 40 mg at bedtime, was similar to that in the placebo group.
  • The following adverse reactions have been reported to occur in more than 1% of patients on therapy with famotidine in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).
  • The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:
  • Body as a Whole
  • Cardiovascular
  • Gastrointestinal
  • Hematologic
  • Hypersensitivity
  • Musculoskeletal
  • Nervous System/Psychiatric
  • Respiratory
  • Skin
  • Special Senses
  • Other
  • The adverse reactions reported for famotidine tablets may also occur with famotidine for oral suspension, famotidine injection in Galaxy plastic container, and famotidine injection. In addition, transient irritation at the injection site has been observed with famotidine injection.
  • In a clinical study in 35 pediatric patients <1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.
  • The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see ). Oral doses of up to 640 mg/day have been given to adult patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
  • The intravenous LD of famotidine for mice and rats ranged from 254-563 mg/kg and the minimum lethal single I.V. dose in dogs was approximately 300 mg/kg. Signs of acute intoxication in I.V. treated dogs were emesis, restlessness, pallor of mucous membranes or redness of mouth and ears, hypotension, tachycardia and collapse. The oral LD of famotidine in male and female rats and mice was greater than 3000 mg/kg and the minimum lethal acute oral dose in dogs exceeded 2000 mg/kg. Famotidine did not produce overt effects at high oral doses in mice, rats, cats and dogs, but induced significant anorexia and growth depression in rabbits starting with 200 mg/kg/day orally.
  • In some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, Famotidine Injection may be administered until oral therapy can be instituted.
  • The recommended dosage for Famotidine Injection in adult patients is 20 mg intravenously q 12 h.
  • The doses and regimen for parenteral administration in patients with GERD have not been established.
  • Check the container for minute leaks prior to use by squeezing the bag firmly. If leaks are found, discard solution as sterility may be impaired. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Do not add supplementary medication. Do not use unless solution is clear and seal is intact.
  • CAUTION
  • FOR INTRAVENOUS USE ONLY
  • Famotidine Injection containing 20 mg of famotidine per 50 mL is a clear, non-preserved, sterile solution premixed in a vehicle made iso-osmotic with sodium chloride. Famotidine Injection is supplied in a carton of 12 x 50 mL single dose GALAXY plastic containers as follows:
  • Store Famotidine Injection in GALAXY containers (PL 2501 Plastic) at room temperature (25u00b0C/77u00b0F). Exposure of the premixed product to excessive heat should be avoided. Brief exposure to temperatures up to 35u00b0C (95u00b0F) does not adversely affect the product.
  • Baxter Healthcare Corporation
  • Printed in USA
  • Baxter and Galaxy are registered trademarks of Baxter International Inc.
  • Rev. May 2018
  • Arrayn- Famotidinen- Injection
  • 20 mg
  • Rx only
  • GALAXYn- Single Dosen- Container
  • 50 mLn- Iso-osmotic
  • NDC 0338-5197-41n- Code 2G3424n- Sterile Nonpyrogenic
  • Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acidand/or sodium hydroxide. pH 5.7 to 6.4
  • Usual Dosage: Intravenously as directed by a physician. See package insert.
  • Cautions:
  • Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag assterility may be impaired. Do not use unless solution is clear.
  • Recommended storage: Room temperature (25u00b0C/77u00b0F). Avoid excessive heat.Brief exposure up to 35u00b0C/95u00b0F does not adversely affect the product.
  • ______________________________________________________________________
  • Baxter and Galaxy are registered trademarks ofBaxter International Inc.n n Deerfield, IL 60015 USA
  • PL 2501 Plastic
  • 07-34-63-666n
  • Arrayn- Baxter n- Array
  • 12 x 50 mL Single Dose Containers Iso-osmotic n- Recommended storage: Room temperature (25u00b0C/77u00b0F)
  • Baxter Healthcare Corporation
  • *FOR BAR CODE POSITION ONLY(01) 20303385197414
  • Arrayn- Baxter n- Array
  • 12 x 50 mL Single Dose Containers Iso-osmotic n- Recommended storage: Room temperature (25u00b0C/77u00b0F)
  • Baxter Healthcare Corporation
  • *FOR BAR CODE POSITION ONLY(01) 20303385197414
  • GALAXY
  • Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to 6.4
  • Usual Dosage: Intravenously as directed by physician. See package insert.
  • Cautions:
  • GALAXY
  • Each 50 mL contains: 20 mg famotidine, USP, 450 mg sodium chloride, USP, and 6.8 mg L-aspartic acid. pH may have been adjusted with additional L-aspartic acid and/or sodium hydroxide. pH 5.7 to 6.4
  • Usual Dosage: Intravenously as directed by physician. See package insert.
  • Cautions:

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